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13:04 EDT 30th September 2016 | BioPortfolio

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Vantrela ER hydrocodone bitartrate regulatory update

Teva's pain treatment recommended for FDA approval

Teva Pharmaceutical Industries' twice-daily tablet Vantrela ER, or hydrocodone bitartrate, has been endorsed for approval by  -More- 

Teva Gains Recommendation for Approval from FDA Advisory Committees for Vantrela ER (hydrocodone bitartrate) Extended-Release Tablets

JERUSALEM--(BUSINESS WIRE)--Jun. 7, 2016-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety ...

FDA panels recommend Teva's Vantrela ER

FDA's Anesthetic and Analgesic Drug Products committee and Drug Safety and Risk Management advisory committee voted 14-3 to recommend approval of Vantrela ER hydrocodone bitartrate (CEP-33237) from Te...

ED Hydrocodone/Acetaminophen Prescriptions in the VA

How have prescribing patterns for hydrocodone/acetaminophen among veterans changed in recent years? Western Journal of Emergency Medicine: Integrating Emergency Care with Population Health

Report: Prescriptions for Hydrocodone-containing Combination Drugs Drop

The switch of hydrocodone-containing combination drugs from Schedule III to the more restrictive Schedule II in October 2014 significantly reduced the number of prescriptions filled for these drugs, a...

Collegium unveils positive topline results for Hydrocodone DETERx clinical study

Collegium Pharmaceutical has unveiled positive topline results from a clinical study evaluating Hydrocodone DETERx as a second product candidate using its proprietary DETERx drug delivery technology p...

FDA warns against combining opioids and benzodiazepines

The FDA has issued a warning regarding the combined use of opioids and benzodiazepines, which may result in serious adverse effects such as difficult or slowed breathing and death, according to a pres...

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Oral Abuse Potential, Pharmacokinetics, and Safety of Once-Daily, Single-Entity, Extended-Release Hydrocodone (HYD) in Recreational Opioid Users.

 A once-daily, extended-release hydrocodone bitartrate tablet with abuse-deterrent properties (Hysingla ER [HYD]) is available for the treatment of chronic pain in appropriate patients. This study e...

Pharmacokinetic Profile and Sustained 24-hour Analgesia of a Once-daily Hydrocodone Bitartrate Extended-release Tablet with Abuse-deterrent Properties.

The purpose of this study was to evaluate the pharmacokinetics (PK) and 24-hour analgesic effectiveness of once-daily, single-entity, extended-release hydrocodone (HYD) with abuse-deterrent properties...

Opioid Treatment Patterns Following Prescription of Immediate-Release Hydrocodone.

Immediate-release (IR) hydrocodone is the most widely prescribed opioid in the United States; however, little is known about the utilization patterns and duration of opioid use among patients prescrib...

Modified extrusion-spheronization as a technique of microencapsulation for stabilization of choline bitartrate using hydrogenated soya bean oil.

Choline bitartrate (CBT) is a vital nutrient for fetal brain development and memory function. It is hygroscopic in nature which is associated with stability related problem during storage such as deve...

Physicians' intention to prescribe hydrocodone combination products after rescheduling: A theory of reasoned action approach.

The U.S. Drug Enforcement Administration (DEA) rescheduled hydrocodone combination products (HCPs) in an attempt to mitigate the prescription opioid epidemic. Many in the medical and pharmacy communit...

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